Description

Caplyta (Lumateperone)

Caplyta is a once-daily prescription capsule used to treat adults with:

• Schizophrenia

• Bipolar I or Bipolar II depression (can be taken alone, or alongside lithium or valproic acid)

• Major Depressive Disorder (MDD) (taken as an add-on therapy along with other antidepressant medicines)

Important Safety Information

Caplyta carries a Boxed Warning (the FDA’s most serious warning) for two major risks:

• Elderly Patients with Dementia-Related Psychosis: Medicines like Caplyta can increase the risk of death in older adults who have lost touch with reality due to confusion and memory loss (dementia). Caplyta is not approved to treat dementia-related psychosis.

• Suicidal Thoughts and Actions: Caplyta and other antidepressants can increase the risk of suicidal thoughts and behaviors in people aged 24 and younger. This risk is highest during the first few months of treatment or when the dose changes.

Before Taking Caplyta

Do not take Caplyta if you are allergic to lumateperone or any other ingredients in the capsules.

Tell your healthcare provider about all of your medical conditions, especially if you have or have had:

• Heart problems or a stroke

• Low or high blood pressure

• Diabetes, high blood sugar, or a family history of diabetes

• High cholesterol (total, LDL, or triglycerides) or low HDL cholesterol

• A low white blood cell count

• Seizures (convulsions)

• Kidney or liver problems

• Pregnancy (or plans to become pregnant)

• Breastfeeding (or plans to breastfeed)

How it Caplyta Works

Caplyta works by modifying and balancing the activity of three major chemical messengers (neurotransmitters) in the brain: dopamine, glutamate, and serotonin . Balancing these chemicals helps relieve symptoms like hallucinations, delusions, and disorganized thoughts in schizophrenia, as well as low mood in depression.

How to Take Caplyta

• Take this medicine exactly as directed by your healthcare provider and follow all prescription label instructions.

• Take 1 capsule each day , with or without food.

• You can take it in the morning or at night, but aim for the same time every day.

• If you miss a dose: Take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose entirely. Do not take two doses at the same time.

Side Effects

Common Side Effects

• Sleepiness or feeling tired

• Dizziness

• Nausea

• Dry mouth

• Diarrhea

Note on Weight & Fertility: Unlike many other antipsychotic medications, Caplyta does not appear to be associated with weight gain. However, it may cause fertility problems in both males and females. Speak with your healthcare provider if you have concerns about fertility.

Serious Side Effects

• • Stroke: Can occur in elderly people with dementia-related psychosis and can lead to death.

  • Neuroleptic Malignant Syndrome (NMS): A rare, serious, and potentially fatal reaction. Call your healthcare provider or go to the nearest emergency room immediately if you experience a high fever, stiff muscles, confusion, sweating, or changes in your breathing and heart rate.